12:00 AM
 | 
Aug 11, 2008
 |  BioCentury  |  Product Development

An ear for the chronic

In its January draft guidance on developing drugs to treat acute bacterial otitis media, FDA gave companies two difficult options: either persuade patients with painful infections to enroll in placebo-controlled trials, or run large superiority studies against active comparators.

OctoPlus N.V. is taking a different tack by targeting second- or third-line treatment of chronic otitis media, which it thinks will have a lower bar to approval than the acute indication. The company recently stopped a Phase II trial of OP-145 after an interim analysis of data from 30 adults showed the peptide met the primary endpoint of improvement in eardrum mucosa as assessed by otoscopic scores.

The company, which had only €3.3 million ($4.9 million) at Dec. 31, hopes that final data, expected...

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